This content is current only at the time of printing. This document was printed on 8 August 2020. A current copy is located at https://apvma.gov.au/node/31941
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Other regulatory functions
Internal reviews
The APVMA had no internal review due in the June quarter 2018. There were 3 internal reviews active at the end of the June quarter 2018.
Internal reviews—June quarter 2018
|
Quarter |
Decision Due within the Qtr |
Finalised within the Qtr |
Finalised that were due within the Qtr |
Finalised within timeframe (%) |
|---|---|---|---|---|
|
Sep 2017 |
0 |
2 |
N/A |
N/A |
|
Dec 2017 |
1 |
4 |
0 |
0 |
|
Mar 2018 |
0 |
1 |
0 |
0 |
| Jun 2018 | 0 | 0 | 0 | N/A |
If an applicant is not satisfied with a decision made by the APVMA an internal review can be requested. These must be completed within 90 days.
Chemical reviews
A chemical review or ‘chemical reconsideration’ is where the APVMA reconsiders the registration of a chemical, if risks to safety and performance have been identified.
The APVMA continued to progress component assessments for the remaining fifteen chemical reviews.
On 28 March 2018 the Macrolide antibiotics review was completed and the regulatory decision report was published on 6 April 2018.
On 28 May 2018 the Polihexanide review was completed and the regulatory decision report was published.
GMP audit program
In the June quarter 2018, the APVMA completed 30 Good Manufacturing Practice (GMP) audits—22 in Australia and 8 overseas—with 82 per cent of GMP audits completed within timeframe.
GMP activity—June quarter 2018
|
Quarter |
Audit location |
Number completed |
Within timeframe |
Within one week of due date |
|---|---|---|---|---|
|
Sep 17 |
Australia |
15 |
93.3% |
100% |
|
Overseas |
6 |
100% |
100% |
|
|
Dec 17 |
Australia |
7 |
85.7% |
100% |
|
Overseas |
4 |
50% |
50% |
|
|
Mar 18 |
Australia |
9 |
89% |
100% |
|
Overseas |
1 |
100% |
100% |
|
|
Jun 18 |
Australia |
22 |
73% |
82% |
|
Overseas |
8 |
88% |
88% |
|
|
Total |
72 |
82% |
89% |
|
Good Manufacturing Practice (GMP) is part of quality assurance in the manufacturing process and relates to both production and quality control.
Compliance statutory notices
There were no statutory notice published in the June quarter 2018.
Notices issued—December quarter 2017
|
Quarter |
Issued |
Finalised |
Within timeframe |
|---|---|---|---|
|
Sep 17 |
0 |
0 |
N/A |
|
Dec 17 |
1* |
0 |
N/A |
|
Mar 18 |
0 |
0 |
N/A |
| Ju 18 | 0 | 0 | N/A |
|
Total |
1* |
0 |
N/A |
*Notice published following determination of the Administrative Appeals Tribunal.
Compliance statutory notices are formal correspondence issued periodically throughout the year from the APVMA under the agvet code and include stop supply or recall notices or substantiation notices.